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9/30/2021

Industry Updates Volume 12

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State of the Pandemic - Still Raging, Even Though Everyone is Getting Tired Of It!

The global pandemic continues to rage, as the worldwide death toll fast approaches 5 Million, and confirmed global Covid infections are now close to a quarter of a Billion.
Deaths in the United States are almost 700,000, followed by nearly 600,000 in Brazil, and 450,000 officially declared in India (but widely believed to be under-reported).
The total Covid death rates per Million in the United States and the UK are almost identical (2,098 and 2,090) but far exceeded by Peru and Brazil (6,131 and 2,831).
Latin America death rates (Mexico, Argentina and Columbia) exceed the U.S./UK death rates, as do several European countries (Italy, Belgium, Czech Republic, Bulgaria, Hungary, Croatia)
Some countries have notably lower death rates (Canada 738; Israel 848; and Ireland 1,054).

However, daily new infections have been close to previous peaks as the Delta surge continues.
The daily death rate is lower than previous results. Global deaths peaked at over 17,000 per day in the January 2021 surge; at 15,800 in the April surge; but peaked at 11,700 in the current surge at the end of August, and have now fallen back to approx 7,000 death/ day
Of these 7,000 daily deaths globally in late September, up to 2,000 have been in the United States as the Delta variant continues to spread.
Lower total deaths overall during the latest surge may be a result of global vaccination, where over 6 billion shots have now been given, with 40% of these in China (which now exceeds 80% inoculation, based on reported numbers.)
In the United States - and other western countries - the vaccination campaign has bifurcated into two different groups:
- Extending vaccination to younger age groups, while also combating the 15-30% of 'hold-outs' who have not been vaccinated.
- Providing 3rd 'booster' shots, as vaccine efficacy - particularly of market leader Pfizer - BionNTech - has waned significantly over 5-8 months, and less effective against Delta.

The Biden administration is making concerted efforts to increase vaccination rates - using a 'carrot and stick' approach. Compulsory vaccination is required in many workplaces. At the same time, the U.S. and Europe have agreed to re-open the skies for mutual travel without quarantine - but only to the vaccinated - from November.
The ‘hold-out’ rate in the United States has declined a little, following the Delta surge, but still stands at 25% of eligible adults, who have declined the Covid vaccine.
In Israel, the hold-out rate of unvaccinated adults has fallen from 23% to 17% following Delta, and the 3rd shot campaign for the rest of the population.
Overall, the U.S. ranks last of G-7 countries in overall vaccination rates, recently passed by Japan.
Conversely, certain countries - including Canada and Ireland - exceed 90% vaccination of eligible adults. Ireland has taken first place in the Bloomberg ranking of Covid resilience, while the U.S. fell to 28th place and Israel to 41st.

Delta has Quietly Changed Public Policy

High rates of breakthrough infections caused by the Delta variant - combined with the waning immunity of current vaccines - has prompted an effective, if unannounced, change in public health policies worldwide.
- Actual infection by Covid has been shown to provide 13 times more protection against reinfection than 2 shots of the Pfizer-BioNTech vaccine.
The case for vaccinations being made is that it reduces the risk of severe outcomes like hospitalization and death by 80-90% in those infected by Delta, and NOT that it protects directly against infection or transmission.

Covid 19 Vaccinations

Given the high rate of breakthrough infections from Delta, the potential community protection of 'herd immunity' is elusive.
See attached figure showing vaccination rates of the ‘best’ countries in the world - even they are not good enough.
McKinsey estimates vaccination rates needed by countries to achieve herd immunity. Ranges from ~100% vaccination in isolated countries like Australia - which have had little natural infection - to < 50% in countries like Brazil.
A key change in the McKinsey model - they assume that "Natural infection is ~100% effective, lasts long enough to reach herd immunity".
In the U.S., sharp differences have emerged between the White House, the FDA and the CDC re: policies for further booster shots of existing vaccines, leading to the resignation of two senior FDA vaccine officials.
Data is not clear whether boosters provide much additional protection to healthy younger adults, but have been recommended for the 65 plus by the FDA, and approved for a wider audience to include younger people with weakened immune systems by the CDC.
The absence of a vaccine which could directly protect against the Delta variant has become evident in this debate - most officials believe that the pandemic will become endemic, with further new variants arising.
Albert Bourla, the CEO of Pfizer, has said that he expects that current vaccines may not be protective against new variants which may arise after Delta.
It is not clear whether issues facing countries which have relied primarily on mRNA vaccines from Pfizer and Moderna (e.g. U.S., UK, Israel) will also apply to countries which have relied primarily on other vaccines, and particularly Whole Inactivated Viral (WIV) vaccines.
If natural infection with the whole virus has been shown to be 13 times more protective than Pfizer after 6 months, then a vaccine which most closely replicates natural infection (a WIV vaccine) should also provide wider, longer term protection.
Four important charts showing infections and death rates included below.

Covid Deaths

Covid Deaths per million people

Confirmed Covid Cases

Confirmed Covid Cases per million people

What the World Needs Next: Market Opportunity

Our conclusion is that what is now urgently needed is a WIV vaccine manufactured and regulated to the top western standards, based directly on Delta and other latest variants.
This would be a meaningful 'booster' for those already inoculated with a Wuhan strain Spike protein vaccine; as well as a much more direct protection for the unvaccinated everywhere.

Graphs courtesy of Our World In Data

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9/3/2021

Covid-19 Vaccines - Is Anything Better Than mRNA?

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Recent analyses of populations experiencing further waves of COVID-19 infection based on the Delta variant indicate that new challenges are emerging in the fight against the COVID-19 Pandemic: Some in-use vaccines are failing to provide long-run protection against the rapidly evolving COVID-19 virus, whereas others appear to be showing better long-term performance. See our analysis in our Industry Update 11.

For example: Double vaccination protocols with Pfizer/BioNTech’s mRNA-base COVID-19 vaccine in Israel did NOT prevent most infections by the Delta variant, although the protocol does reduce the risk of hospitalization for serious COVID-19 illness
Given that Pfizer/BioNTech’s vaccine does not prevent either infection and/or transmission of the Delta variant in many cases, the concept of ‘Herd Immunity’ against Delta becomes moot
- Most COVID-19 policy-decisions world-wide are largely driven on the objective of achieving herd immunity
Israel’s analysis of recovery from a prior natural COVID-19 infection had determined that it provides protection against the Delta variant that is 10X – 13X+ times more powerful than the protection provided by the current Pfizer/ BioNTech two dose protocol
- This has important implications on the need for/frequency of booster shots to maintain strong immunity levels, along with the need to frequently update the vaccine formulations to ‘keep up’ with rapidly evolving COVID-19 variants

Israeli Ministry of Health figures illustrate how two shots of the Pfizer/BioNTech vaccine is providing very little protection against the Delta variant.

Alternatively, evidence is emerging suggesting that vaccines based on the whole virion (Whole Inactivated Virus – WIV vaccines) are providing better and longer-range immunity and protection against the most recent variants
- Driven by the WIV vaccine’s basic structure which is similar to the natural infection of COVID-19 and exposes the immune system to the whole virion, not just the Spike protein

Image from Our World In Data

Data from countries relying substantially on WIV vaccines are NOT experiencing a Delta surge comparable to countries relying predominantly on Spike protein-only vaccines.

There also appear to be marked differences in your immune system after a natural infection with coronavirus and after vaccination.
A substantial amount of research suggests that a second or third shot of a DIFFERENT type of vaccine appears to provide greater protection than more shots of the same. This finding however appears to have been ignored in both the Israeli and US booster shot decisions.

The current situation with vaccines world-wide strongly supports the following hypotheses:

A whole virion (WIV) vaccine creates an immune response that is much closer to actual infection from Covid, as compared to vaccines relying solely on the Spike protein
A whole virion WIV vaccines will therefore provide significantly higher protection against the Delta surge
Any Covid vaccine modeled directly on the Delta variant will provide more protection than the SAME vaccine modeled on the much earlier Wuhan strain (i.e., all current vaccines)
An ideal vaccine should carry 'multiple payloads' as there will be further evolution of new variants, most likely continually derived from the now dominant Delta strain.

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Industry Updates Volume 12

Covid-19 Vaccines - Is Anything Better Than mRNA?

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